Clinical Research Associate (CRA) – Level I | Level II | Senior CRA
Location: India (Onsite)
Job Type: Full-Time
Work Mode: Fully Onsite
Category: Clinical Research
Job ID: R-01326248
Work Schedule: Monday to Friday (Standard Business Hours)
Job Overview
Thermo Fisher Scientific is hiring Clinical Research Associates (CRA) across Level I, Level II, and Senior levels to support global clinical trials within its PPD® Clinical Research Services organization. This opportunity is suited for clinical research professionals at different career stages who are passionate about delivering high-quality clinical trials while ensuring patient safety, data integrity, and regulatory compliance.
As part of a leading global Contract Research Organization (CRO), you will contribute to end-to-end clinical operations across diverse therapeutic areas and study phases, supporting trials conducted in over 100 countries.
Key Responsibilities
Perform and coordinate clinical monitoring and site management activities from study initiation through close-out.
Conduct on-site and remote monitoring visits to ensure compliance with study protocols, ICH-GCP, SOPs, and regulatory requirements.
Apply risk-based monitoring (RBM) principles, including root cause analysis (RCA), to identify, escalate, and resolve site issues.
Ensure data accuracy and quality through Source Data Review (SDR), Source Data Verification (SDV), and CRF review.
Review and manage investigational product accountability, inventory, and storage documentation.
Maintain complete, accurate, and inspection-ready essential documents and TMF records.
Escalate study risks, deviations, and deficiencies to clinical management and follow through to resolution.
Support site initiation, routine monitoring, and close-out visits, including retrieval of study materials.
Facilitate effective communication between investigative sites, sponsors, and internal project teams.
Participate in investigator meetings and support investigator identification and feasibility activities, as required.
Ensure study systems such as CTMS are updated in line with study conventions.
Support audits, inspections, and regulatory queries.
Complete administrative responsibilities including reports, expense claims, and timesheets in a timely manner.
Contribute to continuous process improvement initiatives and project-level documentation.
Experience Requirements (Role-Based)
CRA Level I: Minimum 2+ years of experience as an on-site clinical research monitor.
CRA Level II: 3–5 years of independent monitoring experience across multiple sites and studies.
Senior CRA: 5+ years of clinical monitoring experience with demonstrated ability to manage complex trials and mentor junior CRAs.
Valid driving license and willingness to travel extensively as per study requirements are required.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline
OR
Registered Nursing certification or equivalent relevant academic/vocational qualification
Equivalent combinations of education, training, and experience may be considered.
Required Skills & Competencies
Strong knowledge of ICH-GCP, applicable regulatory guidelines, and clinical trial processes.
Proven expertise in on-site clinical monitoring and site management.
Experience with Risk-Based Monitoring (RBM) methodologies.
Strong critical thinking, problem-solving, and root cause analysis skills.
Excellent written and verbal communication skills with medical and research professionals.
High attention to detail with strong organizational and time management abilities.
Ability to work independently as well as collaboratively within cross-functional teams.
Proficiency in Microsoft Office and ability to learn clinical trial systems and software.
Strong English language and documentation skills.
Work Environment & Travel
Onsite role with exposure to clinical and healthcare environments.
Ability to work in non-traditional settings and manage multiple priorities under pressure.
Independent travel required, including travel by road, rail, and air, based on study needs.
About Thermo Fisher Scientific
Thermo Fisher Scientific is the world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the company delivers end-to-end clinical development solutions across laboratory, digital, and decentralized clinical trial models.
Thermo Fisher Scientific is an Equal Employment Opportunity Employer and values diversity, inclusion, and merit-based growth.
Apply Now
If you are a Clinical Research Associate seeking to grow your career at a global CRO and contribute to life-changing clinical research, apply now and join Thermo Fisher Scientific’s mission to advance science and improve patient outcomes.
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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